Law of Pharmaceutical Preparations and Installations

Article 1

  • The words or phrases mentioned below, wherever they appear in the Law, shall have the meanings specified in front of them, unless the context requires otherwise:

  • The Ministry: Ministry of Health.

  • The Minister: Minister of Health.

  • The Profession: Pharmacy profession.

  • The Pharmacist:

    • Anyone who has obtained a Bachelor's degree in Pharmaceutical Sciences or a Doctor of Pharmacy degree from one of the pharmacy colleges in the Kingdom or its equivalent.

  • The Pharmacy Technician:

    • Anyone who has obtained a Pharmacy Technician certificate from an institute or health college in the Kingdom or its equivalent.

  • The Licensed Pharmacist:

    • Any pharmacist licensed to practice the profession in the Kingdom.

  • The Pharmaceutical Product (Medicine):

    • Any product manufactured in a pharmaceutical manner containing one or more substances used externally or internally for the treatment of humans or animals from diseases or for their prevention.

  • The Herbal Products:

    • Plants and herbs that have a medical claim and are prepared in a pharmaceutical form.

  • The Pharmaceutical Establishment:

    • The pharmacy or establishment selling herbal products, or the pharmaceutical manufacturing plant, or the wholesale warehouse for trading in pharmaceutical and herbal products, or the scientific office of a pharmaceutical company, or the center for pharmaceutical consultations and analysis of pharmaceutical products.

  • The Pharmacy:

    • The pharmaceutical establishment prepared for the preparation and dispensing of pharmaceutical products.

  • The Wholesale Warehouse for Pharmaceutical and Herbal Products:

    • The pharmaceutical establishment licensed to import, distribute, or sell pharmaceutical and herbal products wholesale.

  • The Scientific Office:

    • The pharmaceutical establishment that provides scientific, technical, and marketing information for pharmaceutical products in the Kingdom.

  • The Herbal Products Selling Establishment:

    • The pharmaceutical establishment prepared for the preparation and dispensing of herbal products.

  • The Center for Pharmaceutical Consultations and Analysis of Pharmaceutical Products:

    • The pharmaceutical establishment that provides pharmaceutical consultations, analyzes pharmaceutical and herbal products, studies bioavailability and bioequivalence, monitors the quality of medicines, and determines drug levels in biological fluids.

  • The Regulation: The Implementing Regulation of this Law.

Related files
Hide
Related file link

Article 2

A pharmacy establishment may not be opened except after obtaining the necessary license from the Ministry in the name of the establishment's owner.

Related files
Hide
Related file link

Article 3

  • The ownership of the pharmacy, herbal products sales establishment, or pharmaceutical consultation and analysis center is limited to Saudis. The following conditions must be met for the issuance of the License:

  • A- The owner or one of the partners must be a licensed pharmacist authorized to practice the Profession. Existing establishments are exempt from this requirement except in cases of death, sale, or Waiver. The Minister may suffice with the nationality condition in remote areas specified by the Regulation.

  • B- The manager of the pharmacy, establishment, or center must be a full-time Saudi pharmacist licensed to practice the Profession. The Minister may grant an Exemption from the nationality condition if there are not enough Saudi pharmacists available.

  • C- The pharmacy, establishment, or center must meet the conditions and specifications set forth in the Regulation.

Article 4

  • It is required to grant a License to open a warehouse for the wholesale trade of pharmaceutical and herbal products the following conditions:

  • A- The applicant for the License must be of Saudi nationality, and if an individual, he must be at least twenty-one years old.

  • B- He must not have previously been convicted of a crime that undermines honor and integrity, unless he has been rehabilitated.

  • C- The manager of the warehouse must be a pharmacist or a licensed pharmacy technician who is a Saudi national and is dedicated to practicing the profession.

  • D- The warehouse must meet the conditions and specifications set forth in the Regulation.

Article 5

  • It is required to grant a license to open a factory for pharmaceutical and herbal products the following:

  • A- Obtaining an industrial license from the competent authority.

  • B- The technical manager of the factory must be a licensed Saudi pharmacist dedicated to practicing the profession.

  • C- The factory must meet the conditions and specifications set forth in the regulation.

Article 6

  • Every company or institution manufacturing pharmaceutical products must have a registered factory in the Kingdom; a scientific office, and the following conditions must be met for the license to be granted to the office:

  • A- The office manager must be a licensed Saudi pharmacist who is dedicated to practicing the profession.

  • B- The office must meet the conditions and specifications set forth in the regulation.

Article 7

The duration of the license for the pharmacy establishment is five years, renewable.

Article 8

Article 9

The internal pharmacy license for the hospital is included within its license.

Article 10

The pharmacy establishment is not permitted to employ pharmacists or pharmacy technicians who are not licensed.

Related files
Hide
Related file link

Next section title

Next section content